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FDA Approves Diovan(R) (Valsartan) to Reduce Cardiovascular Death in Heart Attack Survivors at High Risk.

Article Excerpt
Agency Grants First-In-Class Approval Plus Newly Expanded Heart Failure Labeling

EAST HANOVER, N.J., Aug. 3 /PRNewswire-FirstCall/ -- Novartis Pharmaceuticals Corporation announced today that the US Food and Drug Administration (FDA) approved Diovan(R) (valsartan), the most prescribed ARB (angiotensin receptor blocker) in the US and worldwide, for a new indication to reduce cardiovascular death in patients at high risk (with left ventricular failure or left ventricular dysfunction) following a heart attack. The FDA also expanded the drug's heart failure labeling. Diovan can now be prescribed in a broader range of heart failure patients and is no longer limited to those intolerant of ACE inhibitors.

"Millions of patients already rely on Diovan to help them get to goal and maintain healthier blood pressure goals. Now, based on results from one of the largest mega-trial programs in the ARB class, Diovan has demonstrated additional benefits that can address the needs of an even broader spectrum of cardiovascular patients," said Alex Gorsky, Chief Operating Officer, Novartis Pharmaceuticals Corporation. "We remain committed to developing the full clinical potential of this agent."

High blood pressure, a disease which affects more than 65 million Americans, greatly increases the risk of suffering a heart attack or developing heart failure. Each year, 1.2 million Americans suffer a heart attack, which puts them...

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